Generic HYDROCORTISONE INN equivalents, drug patent expiration information and freedom to operate

What are the generic sources for hydrocortisone and what is the scope of freedom to operate?

Hydrocortisone is the generic ingredient in seventy-five branded drugs marketed by Allergan Herbert, Crown Labs, Salix Pharms, Bayer Pharms, Monarch Pharms, Valeant Pharm Intl, Westwood Squibb, Pharm Assoc, C And M Pharma, Actavis Mid Atlantic, Alpharma Us Pharms, Altana, Ambix, Everylife, Fougera Pharms Inc, G And W Labs, Ingram Pharm, Ivax Pharms, Lannett Co Inc, Naska, Perrigo New York, Pharmaderm, Pharmafair, Rising, Stiefel, Syosset, Taro, Taro Pharm Inds Ltd, Teligent Pharma Inc, Teva, Topiderm, Usl Pharma, Whiteworth Town Plsn, Valeant Intl, Bausch, Medicis, Paddock Llc, Ani Pharms, Teva Pharms, Healthpoint, Pharmacia And Upjohn, Baker Norton, Marnel Pharms, Solvay, Beta Dermac, Bluline, Heran, Fougera Pharms, Mericon, Dow Pharm, Perrigo Co, Pfizer Global, Cmp Pharma Inc, Dermik Labs, Torch, X Gen Pharms, Mission Pharma, Pfizer, Barr, Elkins Sinn, Ferrante, Hikma Intl Pharms, Impax Labs, Impax Labs Inc, Inwood Labs, Lannett, Nexgen Pharma Inc, Panray, Parke Davis, PII, Purepac Pharm, Roxane, Sandoz, Vintage, Watson Labs, Merck, Pfipharmecs, Mylan Speciality Lp, Able, Cenci, Ferndale Labs, Sebela Ireland Ltd, Akorn, Bel Mar, Fera Pharms, Colgate, Genus, Glenmark Generics, Taro Pharm Inds, Yamanouchi, Precision Dermat, Lupin Ltd, Abbott, Hospira, Abraxis Pharm, Baxter Hlthcare, Intl Medication, Acp Nimble, Glenmark Pharms Ltd, Perrigo Israel, Sun Pharm Inds Inc, Amring Pharms, Bausch And Lomb, Sandoz Inc, Casper Pharma Llc, Schering, Actavis Labs Fl Inc, Forest Labs, Lederle, and Bioglan, and is included in two hundred and fifty-three NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are sixty-seven drug master file entries for hydrocortisone. Thirty-two suppliers are listed for this compound.

Sponsor	Phase
Azienda Ospedaliero-Universitaria di Modena	Phase 2
Tehran University of Medical Sciences	Phase 3
Salah Eldeen Ibrahim Alsherif	N/A

Sponsor

Phase

Azienda Ospedaliero-Universitaria di Modena

Phase 2

Tehran University of Medical Sciences

Phase 3

Salah Eldeen Ibrahim Alsherif

N/A

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmaderm	HYDROCORTISONE	hydrocortisone	CREAM;TOPICAL	089413-001	Dec 16, 1986		DISCN	No	No	Start Trial	Start Trial				Start Trial
Mericon	HYDROCORTISONE	hydrocortisone	LOTION;TOPICAL	085282-001	Approved Prior to Jan 1, 1982		DISCN	No	No	Start Trial	Start Trial				Start Trial
Bayer Pharms	CORT-DOME	hydrocortisone	LOTION;TOPICAL	009895-001	Approved Prior to Jan 1, 1982		DISCN	No	No	Start Trial	Start Trial				Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Applicant

Tradename

Generic Name

Dosage

NDA

Approval Date

Type

RLD

Patent No.

Patent Expiration

Product

Substance

Delist Req.

Exclusivity Expiration

CREAM;TOPICAL

Dec 16, 1986

DISCN

Start Trial

LOTION;TOPICAL

Approved Prior to Jan 1, 1982

DISCN

Start Trial

LOTION;TOPICAL

Approved Prior to Jan 1, 1982

DISCN

Start Trial

>Applicant

>Tradename

>Generic Name

>Dosage

>NDA

>Approval Date

>TE

>Type

>RLD

>RS

>Patent No.

>Patent Expiration

>Product

>Substance

>Delist Req.

>Exclusivity Expiration

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US Patents:	2
Tradenames:	75
Applicants:	110
NDAs:	253
Drug Master File Entries:	67
Suppliers / Packagers:	32
Bulk Api Vendors:	91
Clinical Trials:	335
Patent Applications:	7,164
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for hydrocortisone
Drug Sales Revenues:	Drug sales revenues for hydrocortisone
DailyMed Link:	hydrocortisone at DailyMed

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Hydrocortisone - Generic Drug Details

What are the generic sources for hydrocortisone and what is the scope of freedom to operate?

Summary for hydrocortisone

Recent Clinical Trials for hydrocortisone

Pharmacology for hydrocortisone

Medical Subject Heading (MeSH) Categories for hydrocortisone

Synonyms for hydrocortisone

US Patents and Regulatory Information for hydrocortisone

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(11alpha,14beta)-11,17,21-Trihydroxypregn-4-Ene-3,20-Dione
(11beta)-11,17,21-Trihydroxy-pregn-4-ene-3,20-dione
(11beta)-11,17,21-trihydroxypregn-4-ene-3,20-dione
(1S,10S,11S,15S,17S,2R,14R)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyl tetracyclo[8.7.0.0<2,7>.0<11,15>]heptadec-6-en-5-one
(1S,2R,10S,11S,14R,15S,17S)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-5-one
(1S,2R,10S,11S,14R,15S,17S)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0(2),.0(1)(1),(1)]heptadec-6-en-5-one
(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one
(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-3-one
(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3(2H)-one
(8xi,9xi,11beta,14xi)-11,17,21-trihydroxypregn-4-ene-3,20-dione
[3H]cortisol
1050676-88-4
11-beta-Hydrocortisone
11-beta-Hydroxycortisone
11-Hydrocortisone
11,17,21-Trihydroxypregn-4-ene-3,20-dione, (11.beta.)-
11?,17?,21-Trihydroxypregn-4-ene-3,20-dione
11.beta.-Hydrocortisone
11.beta.-Hydroxycortisone
11.beta.,17,21-Trihydroxypregn-4-ene-3,20-dione
11.beta.,17,21-trihydroxyprogesterone
11.beta.,17.alpha.,21-Trihydroxy-4-pregnene-3,20-dione
11.beta.,17.alpha.,21-Trihydroxypregn-4-ene-3,20-dione
11\|A,17\|A,21-Trihydroxypregn-4-ene-3,20-dione; 17-Hydroxycorticosterone; 4-Pregnene-11\|A,17\|A,21-triol-3,20-dione; Cortisol; Kendall inverted exclamation mark s compound F; Reichstein inverted exclamation mark s substance M
11a-Hydroxycorticosterone
11alpha-Hydroxycorticosterone
11b-Hydrocortisone
11b-Hydroxycortisone
11b,17,21-Trihydroxyprogesterone
11beta-cortisol
11beta-Hydrocortisone
11beta-Hydroxycortisone
11beta,17,21-Trihydroxypregn-4-ene-3,20-dione
11beta,17,21-Trihydroxyprogesterone
11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione
11beta,17alpha,21-Trihydroxypregn-4-ene-3,20-dione
1436392-18-5
17-Hydroxycorticosterone
17.alpha.-Hydroxycorticosterone
17a-Hydroxycorticosterone